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FDA Risk Communication

FDA Risk Communication. Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee February 28, 2008. FDA’s Mission. Protect public health assure safety, effectiveness, security of regulated products Advance public health

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FDA Risk Communication

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  1. FDA Risk Communication Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee February 28, 2008

  2. FDA’s Mission • Protect public health • assure safety, effectiveness, security of regulated products • Advance public health • speed innovations that make medicines and foods more effective, safer, more affordable • help public get accurate, science-based information needed to use medicines and foods to improve health

  3. Products Regulated by FDA • Foods • Drugs • Biologics • blood, tissues, non-therapeutic vaccines • Medical devices • Cosmetics • Veterinary & Animal • Radiation-emitting electronic products

  4. Keyword: Complexity • Different products, different authorities • often within broad product categories • Organizational structure defined by product categories • Multiple audiences with differing needs • primary audience also differs by product

  5. Foods & Cosmetics • Only broad product category where • primary audience is general public • limited pre-market approval authority • Historical recognition of importance of effective communication to public • consumer research was critical input to development of Nutrition Facts labeling

  6. Medical Products • Historically, communication focused on health care providers • in 1500s, physicians fined if they told patients even the names of medicines • 1938 Federal Register notice: write drug labeling “only in such medical terms as are not likely to be understood by the ordinary individual” • Significant challenges to FDA attempts to expand labeling to include patients

  7. Clearly, the environment has changed!

  8. Some Significant Changes • Increasing consumer empowerment and patient advocacy • concerns of aging population • increased sophistication, expectations • New and expanded media • Rapid development of new treatments • often with unique complexities • Recognition of impact of literacy limitations

  9. How do we communicate?

  10. FDA Communicates Indirectly • Regulation of labels and labeling • general public for some products • foods, cosmetics, OTC products • (mostly) health care providers for medical products • Regulation of advertisements • for prescription drugs & biologics and restricted medical devices • otherwise, ads regulated by FTC

  11. But there are limitations • Some labeling reviewed, some not, before public use • “approved” versus “promotional” • Advertisements generally not reviewed before public use • Can take enforcement action only if law is violated • law often does not address communication issues

  12. FDA Communicates Directly • Press releases • Public education campaigns • Direct response to inquiries • Variety of tools regarding specific products and product classes (more this afternoon) • Limitations apply here as well

  13. How effectively are we communicating?

  14. Effectiveness • Is it too much or too little? • when is “more” actually “less”? • When to communicate? • What means should we, can we, use? • How do we know how we’re doing? • “Everyone’s a critic”

  15. Feedback • Ongoing, on particular topics, e.g., • direct-to-consumer advertising of Rx drugs • notifying the public about emerging risks of medical products • health claims on foods & dietary supplements • Result of direct requests • “Future of Drug Safety” IOM report • FDAAA

  16. December 2005 Public Hearing • Recommendations on CDER’s risk communication strategies • engage health care providers • improve internet access for patient information • need benefit-risk balance in communications • standardize multitude of communication tools • address needs of those with low health literacy and poor English skills • Already addressing some

  17. “Future of Drug Safety” • Institute of Medicine Report about drug safety in general • “Communicating about Safety” chapter • Two recommendations • CDER should develop a cohesive risk communication plan • Congress should establish FDA advisory committee on communication with patients and consumers

  18. Risk Communication Advisory Committee: Function • Advise FDA on strategies and programs to communicate with the public about the risks and benefits of regulated products to facilitate optimal use • Review and evaluate relevant research • Facilitate interactively sharing risk and benefit information with public to enable people to make informed independent judgments about use of regulated products

  19. Risk Communication Advisory Committee: Composition • Composition different from most Advisory Committees • Importance of including the perspectives of our varied real-world audiences • “experiential insight on the communication needs” of the users of FDA-regulated products • Ramifications of coverage of multiple products

  20. Risk Communication Advisory Committee: Focus • General practices and processes • overall needs of different audiences (patients, consumers, providers, media, industry) • internet • Issues relevant to large product categories • foods vs. medical products • maybe different medical products, e.g., regarding consumer-directed advertisements

  21. The Long View

  22. More Immediate View • Today • AM: FDA’s authorities and constraints on our activities and a little about FDAAA • PM: open public hearing, followed by key FDA risk communication activities and discussion of possible scenarios • Tomorrow’s focus is recall press releases • AM: background and open public hearing • PM: committee discussion

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